Table of contents:
- Recent Developments of Candidates for COVID-19 Vaccines
- 1. The COVID-19 vaccine University of Oxford/ Astrazeneca, England
- Preclinic
- Clinical Trials Phase 1 and 2
- Phase 3 Clinical Trials
- 1,024,298
- 831,330
- 28,855
- 2.Sinovac COVID-19 vaccine from China
- Phase 1 Clinical Trials
- Phase 2 Clinical Trials
- Phase 3 Clinical Trials
- 3. Moderna's COVID-19 vaccine from the United States
- Preclinic
- Phase 1 Clinical Trials
- Phase 2 Clinical Trials
- Phase 3 Clinical Trials
- 4. CanSino Biologics / Beijing Institute of Biotechnology
- Phase 1 Clinical Trials
- Phase 2 Clinical Trials
- 5. Sinopharm's COVID-19 vaccine
- Phase 3 Clinical Trials
- 6. Pfizer / BioNTech / Fosun Pharmaceutical
- Clinical Trials Phase 1 and 2
- Phase 3 Clinical Trials
- 7. Novavax
- 8. Sputnik Vaccine
- Vaccine Manufacturing Stages You Need to Know
Read all articles about coronavirus (COVID-19) here.
There are hundreds of COVID-19 vaccine candidates being developed in various countries around the world. Starting from vaccines developed by weakening the corona virus to those made from genetic pieces of the virus.
Vaccine development generally takes years before it reaches the human testing stage and can be used en masse. But to fight COVID-19, scientists are rushing their best to complete vaccine development in no time.
Which COVID-19 vaccine candidates have the potential to successfully pass the test? Why do many countries develop their own vaccines by involving other countries as clinical trials? Check out the following reviews.
Recent Developments of Candidates for COVID-19 Vaccines
1. The COVID-19 vaccine University of Oxford / Astrazeneca, England
The COVID-19 vaccine candidate developed by researchers from the University of Oxford, England, in collaboration with the Astrazeneca pharmaceutical company, is currently called ChAdOx1 nCoV-19 or known as the Oxford Vaccine.
This vaccine will be made from an active adenovirus, a flu virus that commonly attacks chimpanzees. Researchers weakened the virus so that it was harmless to the human body, then added the genetic code of the SARS-CoV-2 virus that causes COVID-19.
Preclinic
Research on monkeys shows this vaccine can provide protection from the Coronavirus. Although the vaccine candidate did not prevent the monkey from becoming infected with the Coronavirus, it could prevent him from experiencing symptoms of illness. Preclinical results published in mid-May (13/5/2020).
Clinical Trials Phase 1 and 2
This phase of clinical trials shows the Oxford vaccine is able to trigger antibodies and other body defense cells against the SARS-CoV-2 virus that causes COVID-19. This vaccine candidate has also been shown to be safe and does not cause serious side effects in the test participants. The results of the phase 1/2 clinical trial were published on July (20/7/2020).
Phase 3 Clinical Trials
The final stage clinical trial is being conducted in Brazil and will involve a total of 5,000 participants. Oxford clinical trials of the COVID-19 vaccine are also being carried out in the UK, India and South Africa.
The Astrazeneca vaccine phase 3 clinical trial should be temporarily suspended (2/9). This was done because in a clinical trial in the UK there were suspicions of unexplained disease reactions.
COVID-19 Outbreak updates Country: IndonesiaData
1,024,298
Confirmed831,330
Recovered28,855
DeathDistribution Map2.Sinovac COVID-19 vaccine from China
This one COVID-19 vaccine plan was developed by Sinovac Biotech, a biotechnology company from China. The development of this vaccine is made from the whole SARS-CoV-2 virus that has been inactivated.
Phase 1 Clinical Trials
Testing was conducted on 144 participants consisting of adults aged 18-59 years.
Phase 2 Clinical Trials
This phase 2 trial involved 600 participants in the same age range as the phase 1 clinical trial.
The results from the phase 1 and 2 clinical trials were reported safe and there were no serious side effects in the participants. The results of phase 2 clinical trials show that this vaccine will be able to trigger the formation of antibodies that can neutralize the SARS-CoV-2 virus that causes COVID-19.
Phase 3 Clinical Trials
Sinovac conducted trials on 9,000 participants in Brazil and 4,200 participants in Bangladesh. This August, Sinovac is also working with an Indonesian pharmaceutical company, Bio Farma, to conduct a trial in Bandung which will involve 1,620 volunteers.
On Thursday (10/9) it was announced that one of the volunteers in Bandung had tested positive for COVID-19 when a swab test was carried out on the second injection of the vaccine.
3. Moderna's COVID-19 vaccine from the United States
The Moderna vaccine was developed by the biotechnology company Moderna and the US National Institutes of Health (NNH). The vaccine candidate, called mRNA-1273, was developed from the genetically engineered mRNA or SARS-CoV-2 virus.
Preclinic
Based on the results of experiments on animals, this vaccine can protect monkeys from Coronavirus infection.
Phase 1 Clinical Trials
The phase 1 clinical trial was carried out last March and is said to be the first to test the COVID19 vaccine candidate in humans.
Phase 2 Clinical Trials
The second phase of the trial was carried out by involving 600 participants.
Phase 3 Clinical Trials
This final stage test was conducted on 30,000 participants in 89 regions in the United States.
Monday (16/11), Moderna announced the preliminary results of the phase 3 clinical trial showing that this vaccine was 94.5% effective in preventing COVID-19.
After 30,000 participants received two doses of vaccination, 95 people tested positive for COVID-19. Of the 95 people who tested positive, 90 of them were in the group that received the placebo vaccine, a vaccine designed to have no effect, and only 5 people received two doses of the original vaccine.
"An interim analysis of our phase 3 clinical trial results has validated that our vaccine can prevent COVID-19 including its bad symptoms," said CEO of Moderna, Stephane Bencel.
4. CanSino Biologics / Beijing Institute of Biotechnology
Chinese company CanSino Biologics is working with the Institute of Biology at Academy of Military Medical Sciences developing the COVID-19 vaccine from Adenovirus. Unlike Oxford, this COVID-19 vaccine candidate uses a type of Adenovirus that infects humans.
Phase 1 Clinical Trials
The first phase trial was completed last May with safe and promising results.
Phase 2 Clinical Trials
Phase 2 human trials were carried out in Wuhan involving 508 participants.
5. Sinopharm's COVID-19 vaccine
China National Pharmaceutical Group (Sinopharm) tested two COVID-19 vaccine candidates, namely those developed by Beijing Institute of Biological Products and developed by Wuhan Institute .
Phase 3 Clinical Trials
The final human trials on this vaccine were conducted in the United Arab Emirates, with both versions of the vaccine involving 5000 participants each.
6. Pfizer / BioNTech / Fosun Pharmaceutical
The German company BioNTech has a partnership with Pfizer and the pharmaceutical company Fosun. They developed an mRNA-type vaccine.
Clinical Trials Phase 1 and 2
The first-stage human trials proved successful in triggering antibodies against SARS-CoV-2. The vaccine is proven to be safe and does not cause serious side effects, except that some participants in this stage of the test reported experiencing sleep disturbances and arm pain.
Phase 3 Clinical Trials
This phase of the trial was carried out involving 30,000 participants in the United States and several other countries, including Argentina, Brazil and Germany.
Tuesday (9/11), an analysis of interim results from a phase 3 clinical trial showed that the vaccine made by Pfizer was 90% effective in preventing COVID-19. After 44,000 participants received two doses of vaccination, 94 people tested positive for COVID-19 with symptoms. But Pfizer has not announced how many of these COVID-19 positive participants received the original vaccine and how many received the placebo, which is designed to have no effect.
7. Novavax
This vaccine candidate is made by the Novavax company based in Maryland, United States. This vaccine is made by attaching proteins to microscopic particles (particles of atomic-molecular size). In this way they can make vaccines for three different diseases, one of which is for the flu vaccine which has already completed its phase 3 clinical trial last March.
The preclinical phase carried out on monkeys is said to show very promising results. with promising results, safe and proven to grow antibodies. Vaccinated monkeys developed strong antibody protection against the SARS-CoV-2 virus.
Phase 1 clinical trials: The phase 1 clinical trial of the Novavax COVID-19 vaccine candidate was launched last May. In addition to being proven safe, in this phase 1 clinical trial, volunteers showed a high immune response.
Phase 2 clinical trials: Conducted on 2,900 participants in South Africa.
Phase 3 clinical trials: Update on September 22nd, clinical trials in the final phase of this Novavax vaccine candidate will begin to be carried out on 10,000 participants in the United Kingdom. A phase 3 trial with more volunteers will begin in America in early October.
Despite being about a month behind other COVID-19 vaccine candidates, experts say Novavax is one of the most promising candidates.
8. Sputnik Vaccine
The candidate for this sputnik COVID-19 vaccine is made by The Gamaleya Research Institute, an institution under the Russian Ministry of Health. It is a combination of two adenoviruses called Ad5 and Ad26, both of which were engineered with the coronavirus gene.
Tuesday (11/8) Russian President Vladimir Putin announced the approval of this vaccine to be used and caused great controversy among vaccine experts. The decision to use this vaccine was even made before entering the phase 3 clinical trial and at that time the results of the phase 1/2 clinical trial had not yet been published.
Russia later withdrew the decision and declared the agreement only for limited and conditional use.
Phase 1/2 clinical trial: Friday (4/9), Gamaleya researchers published the results of a phase 1/2 clinical trial, they announced that the sputnik vaccine produces antibodies against the SARS-CoV-2 virus that causes COVID-19 and minor side effects.
Phase 3 clinical trials: Wednesday (11/11), Russia announced preliminary evidence from their Phase 3 trial showing that the vaccine is effective. Based on the 20 positive cases of COVID-19 among the trial participants, Russian scientists estimate that the vaccine shows an efficacy of 92 percent.
Vaccine Manufacturing Stages You Need to Know
Vaccine development is by far the best option for stopping the COVID-19 pandemic worldwide. But making a vaccine is not an easy matter, there are long stages to go through.
Each vaccine candidate must go through pre-clinic, namely testing on animals. Testing on animals (usually in mice or monkeys) is the initial stage to find out whether this vaccine can trigger a strong immune response or not.
After passing pre-clinical trials, according to the American Center for Disease Control (CDC), clinical trials on vaccines are required to go through 3 phases of testing.
In phase 1 clinical trials, scientists will give a vaccine to a small number of people to make sure the vaccine is successful in stimulating the immune system.
Entering phase 2, the study is expanded and vaccines are given to people whose characteristics such as age and physical health are similar to those of the infected person. Clinical trials at this stage are conducted to further examine the safety of the vaccine candidate and its ability to stimulate an immune response.
So far, the COVID-19 vaccine candidates that have gone through phase 2 of clinical trials are on average doing their trials in the 18-55 year age group. So it is not yet known whether the vaccine will be effective in the age group outside the test participants, especially the elderly who have a higher risk of being infected with COVID-19 and are less likely to have a strong immune response.
Moving on to phase 3, testing is carried out on a large number of people (thousands) and waiting to see the number of infected participants.
This stage 3 test is to determine whether the vaccine candidate can provide protection from COVID-19 infection. Specifically for the COVID-19 vaccine, WHO said the vaccine candidate only needed to be effective in protecting at least 50% of the vaccinated people.
The most effective way in a late stage clinical trial is to test it in large numbers of participants in red zones or areas with high transmission rates. Therefore, vaccine candidates entering phase three clinical trials involve several countries in the testing process.